Informations générales (source: ClinicalTrials.gov)
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement (ICAN)
Interventional
N/A
Mativa-Tech SA (Voir sur ClinicalTrials)
janvier 2023
janvier 2025
29 juin 2024
The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized,
interventional study is to assess for the first time the effects of a Combo with
probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis
(NASH) patients with mild or severe fibrosis.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle ROSA, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Diagnosis of moderate to severe NASH :
- chronic liver disease: biological abnormalities for more than 6 months
characteristic ultrasound aspects
- metabolic syndrome
- liver stiffness assessed by FibroScan between 8 and 15kPa
- Adults
- Affiliated to a social security
- Women using effective contraception (hormonal or mechanical) for the duration of the
srudy
- Diagnosis of moderate to severe NASH :
- chronic liver disease: biological abnormalities for more than 6 months
characteristic ultrasound aspects
- metabolic syndrome
- liver stiffness assessed by FibroScan between 8 and 15kPa
- Adults
- Affiliated to a social security
- Women using effective contraception (hormonal or mechanical) for the duration of the
srudy
- Pregnancy
- Excessive alcohol consumption (>100g/week)
- Cirrhosis (elastometry > 15kPa)
- hepato-cellular carcinoma
- Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen
- Viral hepatitis
- Auto immune hepatitis
- anticoagulant therapy
- antibiotics in the month prior to inclusion
- allergic to soya, aspirin, fish, E110 dye, Maltodextrin
- poorly controlled diabetes (Glycated Hemoglobin >8%)
- inclusion in a drug interventional trial